Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to HIV-Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Nelfinavir mesylate (Drug); Delavirdine mesylate (Drug); Stavudine (Drug); Didanosine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pharmacia and Upjohn
Summary
The purpose of this study is to see if it is safe and effective to give combinations of three
or four anti-HIV drugs to HIV-infected patients. The drugs used in this study are delavirdine
(DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).
Clinical Details
Official title: An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens in HIV-1 Infected Individuals
Study design: Treatment, Safety Study
Detailed description:
This is a multicenter, open-label study. Patients are stratified by HIV-1 RNA levels (20,000
to 200,000 copies/ml and greater than 200,000 copies/ml). Patients are equally randomized to
one of four groups and receive antiretroviral therapy for 24 weeks. Group 1 receives
delavirdine (DLV) plus nelfinavir (NFV) plus stavudine (d4T). Group 2 receives DLV plus NFV
plus didanosine (ddI). Group 3 receives NFV plus d4T plus ddI. Group 4 receives DLV plus NFV
plus d4T plus ddI. Patients are evaluated for drug safety and viral burden. Patients may opt
to continue on the study for 24 additional weeks, at the discretion of the investigator.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
You may be eligible for this study if you:
- Are at least 18 years old.
- Are HIV-positive.
- Have a CD4 count of at least 50 cells/mm3.
- Have a viral load of at least 20,000 copies/ml.
Exclusion Criteria
You will not be eligible for this study if you:
- Have taken d4T.
- Have taken protease inhibitors, including NFV.
- Have taken nonnucleoside reverse transcriptase inhibitors.
- Have taken ddI for 1 month or more.
Locations and Contacts
Pharmacia & Upjohn, Peapack, New Jersey 07977, United States
Additional Information
Last updated: June 23, 2005
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